Vetted consultants
How we vet consultants
Only firms that pass our review are listed here.
- We assess regulatory experience, service scope, and professional credentials.
- Approved status may be revoked if standards are not maintained.
February 5, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
Clinical Evaluation and Investigations for Medical Devices in Finland
1. Overview of Clinical Investigations
Clinical investigation is any systematic investigation involving human subjects to assess safety or performance of a medical device, per Regulation (EU) 2017/745 (MDR). Requirements in Chapter I of Annex XV apply to all investigations. Fimea must be notified of all clinical investigations; most require authorisation, some notification. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
2. Types Requiring Authorisation or Notification
- Article 62: Authorisation required for non-CE marked devices or CE-marked outside intended purpose, if results used in conformity assessment.
- Article 82: Authorisation for other investigations (e.g., investigator-driven with CE-marked devices).
- Article 74(1): Notification for PMCF with additional invasive/burdensome procedures. Guidance: MDCG 2021-6 on regulatory pathways. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
3. Submission to Fimea
Use MDCG 2021-08 application form. Submit electronically via secure mail to clinicaltrials@fimea.fi or post. Supporting documents per checklists; must include ethics committee opinion. Documents in Finnish, Swedish, or English; key summaries in Finnish/Swedish. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
4. Processing and Deadlines
Validation phase followed by assessment. Deadlines per MDR Articles 70-71 and national law. Investigation may start after authorisation (or validation for certain cases) and no negative ethics opinion. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
5. Modifications, Adverse Events, and Reporting
Substantial modifications: Notify within one week using MDCG 2021-28 form. Adverse events: Report per MDCG 2020-10/1. Termination/halt: Notify within 15 days (24 hours if safety grounds). Final report: Within one year of end (three months for early termination), with lay summary. Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
6. Fees and Additional Guidance
Fees per Fimea decree. National law: Medical Devices Act 719/2021 and Administrative Regulation 1/2022. Ethics: National Committee on Medical Research Ethics (Tukija). Source: Fimea Clinical Evaluation and Investigations Page https://fimea.fi/en/medical-devices/investigations-with-devices/clinical-evaluation-and-clinical-investigations
Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
Registered Pharmacist · AI Engineer · Director, ElendiLabs
Registered pharmacist, AI engineer, HKHAIS founder, and pharmaceutical & medical device SEO/GEO specialist.
Ask Anything
We'll follow up with you personally.
100% response rate • Reply within 7 business days
Related Articles
Approximately 5 minutes
Obligations for Medical Device Distributors and Importers in Finland
In Finland, distributors and importers of medical devices must comply with MDR and IVDR obligations, including verification of conformity, proper storage/transport, language requirements in Finnish and Swedish, and vigilance reporting to Fimea.
Approximately 5 minutes
Regulation of Products without Intended Medical Purpose in Finland
In Finland, products without an intended medical purpose listed in Annex XVI of the MDR are regulated as medical devices, subject to conformity assessment, CE marking, and common specifications, with transitional provisions until June 2028.
Approximately 5 minutes
Advertising and Promotion Requirements for Medical Devices in Finland
In Finland, advertising of medical devices must comply with MDR/IVDR Article 7 and national law, prohibiting misleading claims, requiring indication of CE marking and manufacturer details, and ensuring information targets the correct user group.
Approximately 5 minutes
EUDAMED Registration Requirements for Medical Device Operators and Devices in Finland
Finnish operators under MDR/IVDR must register actors and devices in EUDAMED or the national CERE register depending on role; manufacturers, authorised representatives, importers, and certain others register directly in EUDAMED.
Approximately 5 minutes
Finland's CERE Register: When and How to Notify Operators and Devices Outside EUDAMED
In Finland, certain medical device operators (e.g., custom-made device manufacturers, health institution self-manufacturers, specific distributors) must notify to the national CERE register rather than EUDAMED, using e-submissions or forms before placing devices on the market.
Approximately 5 minutes
Public Access to Details of CERE-Registered Medical Device Operators in Finland
Finland publishes monthly PDF lists of operators registered in the national CERE register (distributors, custom-made device manufacturers, in-house health institution manufacturers) to provide public visibility equivalent to EUDAMED.